NCT03865316已完成不适用
Comparison of Depth of Sedation Performance Between SedLine and Comparator Device During General Anesthesia
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Correlation of Sedation Indices Performance Across Anesthesia Range
研究概览
简要总结
The primary objective is to compare the performance of Masimo's SedLine and the comparator's device systems during surgery. Relative accuracy of the individual depth of sedation indices will be compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years old and older at the time of consent.
- •ASA status I, II, or III.
- •English-speaking subjects.
- •Scheduled for surgical and non-surgical procedures scheduled under general anesthesia (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc.).
排除标准
- •Any deformities or devices that may prevent application of EEG Sensor to forehead with a proper fit.
- •Subjects who are developmentally delayed.
- •Subjects deemed not suitable for study at the discretion of the investigator.
研究组 & 干预措施
SedLine Vs Comparator Test Group
Experimental
干预措施: SedLine Vs Comparator Test Group (Device)
结局指标
主要结局
Correlation of Sedation Indices Performance Across Anesthesia Range
时间窗: Duration of surgery
The correlation was computed using 1 min average values between the PSi and the comparator's sedation index.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Clinical comparison of two anesthetic depth monitors; Noxious Stimulation Response Index(NSRI) versus BISPatients undergoing elective surgery under general anesthesiaJPRN-UMIN000019633Toho University Sakura medical center Department of anesthesiology60
Unknown
不适用
Can CSM Monitor Depth of Anaesthesia Just as Good as BIS?General AnaesthesiaNCT00251810Oslo University Hospital60
Unknown
不适用
Comparative Population Pharmacodynamic Modeling for Sevoflurane Effects Using ADMS and Bispectral IndexAnesthesiaNCT03069456Chonnam National University Hospital30
已完成
不适用
Epidural Catheter Thread Between Two Different VendorsLabor PainNCT03722446University of Michigan257
已完成
不适用
Epidrum for Thoracic Epidural AnalgesiaPainNCT01597466Hopital Foch46